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A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease (Open PRIDE-HD)

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ClinicalTrials.gov Identifier: NCT02494778
Recruitment Status : Terminated (This study served its purpose in providing considerable safety data. The decision to terminate the studies was not based on any new or emerging safety concern.)
First Posted : July 10, 2015
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
The purpose of the study is to collect and assess long term data on the safety, tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Pridopidine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)
Actual Study Start Date : September 24, 2015
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pridopidine
The mode of administration is oral. Capsules will be swallowed whole with water. One capsule should be taken in the morning and 1 in the afternoon, 7 to 10 hours after the morning dose. Study drug can be taken irrespective of meals.
Drug: Pridopidine
45 mg BID
Other Name: TV7820




Primary Outcome Measures :
  1. Percentage of participants with adverse events [ Time Frame: 364 weeks ]
    Study participation will continue until the drug has been authorized for marketing by the respective regulatory authorities in the USA or Europe; or the study is discontinued for medical/scientific (risk-benefit) or commercial reasons.


Secondary Outcome Measures :
  1. Proportion of subjects (%) who prematurely discontinued from the study [ Time Frame: 364 weeks ]
  2. Proportion of subjects (%) who prematurely discontinued from the study due to AEs [ Time Frame: 364 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pride HD completion within the last 6 months, including 2 week follow up period or patients who transitioned from the Open HART study or patients who complete future safety and efficacy clinical trials of pridopidine. In addition, patients who have already completed their defined study period under Open PRIDE HD global or local amendments and have discontinued treatment with pridopidine will be allowed to re enter the Open PRIDE HD study.
  • Women of child bearing potential or male participants: Adequate contraception and birth control
  • Good general health

    • other criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD;
  • Similar concomitant medication restrictions to PRIDE HD.

    • other criteria apply, please contact the investigator for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494778


  Show 46 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02494778     History of Changes
Other Study ID Numbers: TV7820-CNS-20016
2015-000904-24 ( EudraCT Number )
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Huntington's disease, pridopidine

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders